MAUDE Adverse Event Report: AESCULAP AG TC HALSEY NEEDLE HOLDER SERR 130MM; GENERAL SURGICAL INSTRUMENTS

Model Number BM012R

Device Problems Break (1069); Corroded (1131); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Initial report 9610612-2020-00211 includes devices with different batches.This was noted after sample receipt.This initial report is to report another batch for this malfunction.

Event Description

It was reported that there was an issue with needle holder.It was reported that the with these broken needholders the surgeon noted the error before use, when picking up the device and prior to use on the patient; the tip was missing.It was confirmed that the devices did not break in the sterile field and none have fallen in or had to be removed form a patient.There was no patient harm.A revision surgery was not necessary.An additional medical intervention was not necessary./ this event/malfunction did not prolonged the surgery.Additional information was not provided nor available / was not available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results after receipt of the goods: the needle holder is in a worn condition, one tungsten carbide inlay is broken off, the other inlay is missing and not available for investigation.Sign of corrosion can be found at the solder joint.The device quality and manufacturing history records will be checked for the lot number 450264396.If the review shows any conspicuities,the report will be updated and actions will be initiated.No similar incidents have been filed with products from this batch.The failure is most probably caused due to insufficient maintenance of the device.Discoloration and erosion of materials at solder points and sintered carbide inserts made of tungsten carbide and cobalt can be caused by chemical and electrochemical effects only in connection with an excessive acid content with stainless steel, soldering points and/or long-term impact of water/condensate in the case of stainless steel.Erosion most likely lead to breakage of the carbide inlays.For safe usage a correct reprocessing is necessary.Further information can be found in the reprocessing of instruments to retain value.

Event Description

Medwatch report: 9610612-2020-00386 - (b)(4)- quantity: 1.Associated medwatch report: 9610612-2020-00211 - (b)(4)- quantity: 3.

• Brand Name: TC HALSEY NEEDLE HOLDER SERR 130MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10351360
• MDR Text Key: 204750472
• Report Number: 9610612-2020-00386
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM012R
• Device Catalogue Number: BM012R
• Device Lot Number: 4502643964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1